Quality Assurance Associate (Pharmaceuticals)

Sarah Cannon Research Institute; Nashville (TN); À distance; USD 60 000 - 90 000; Plein temps

Résumé du poste

Sarah Cannon Research Institute (SCRI) is seeking a Clinical Project Associate to ensure the Trial Master File is set up and maintained in audit-ready condition. You will manage TMF/eTMF document collection and perform quality reviews throughout the trial lifecycle.

Role involves coordinating with investigators, sites, and cross-functional teams to ensure timely delivery of study documents and regulatory compliance.

Qualifications

• High School Diploma or GED required.
• 1 year of clinical research experience required; 3 years preferred.
• Oncology clinical research experience preferred.

Responsabilités

• Set up and maintain the TMF/eTMF in audit-ready condition.
• Perform initial quality review of documents prior to upload.
• Collaborate with document specialists to maintain TMF/eTMF from study start to completion.
• Assist with verifying qualifications of investigators and sites during the trial.
• Distribute and collect essential trial documents with sites and resolve regulatory issues.
• Review study documents to ensure currency and completeness.

Connaissances

Clinical research experience

Oncology experience

Formation

High School Diploma or GED

Description du poste

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

Clinical Project Associate , you are responsible for ensuring the Trial Master File (TMF) is set-up and maintained in “audit ready” condition; and conduct critical documentation collection and review throughout the lifecycle of the study, in accordance with Good Clinical Practices, ICH Guidelines, Federal Regulations and Development Innovations SOPs. You will maintain clinical trial management systems and tracking tools, actively participating in cross-functional teams to ensure delivery of project deliverables.

This position is remote based in the US; relocation assistance and visa sponsorship are not available.

• You will set-up, document collection/upload of files to the TMF/eTMF
• You will perform initial quality review of documents prior to upload/filing in the TMF/eTMF
• You will partner with document specialist to maintain the Trial Master File (TMF) in “audit ready” condition from study start to completion
• You will assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial
• You perform critical document distribution to and collection from the investigative sites throughout the lifecycle of the clinical trial. Proactively liaise with Clinical Research Associate and investigative site to resolve outstanding regulatory issues
• You review study documents to ensure they are current, complete and accurate

• Minimum High School Diploma or GED
• At least 1 year of clinical research experience required; at least 3 years of clinical research experience preferred.
• Oncology clinical research experience preferred

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.to learn more about our research offerings.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.